MAUDE Adverse Event Report: TORNIER INC PERFORM HUMERAL IMPACTOR TIP SIZE 3/4

Catalog Number	MWM052
Medical Device Problem Codes	Break (1069); Fracture (1260)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there is a broken mwm052 (perform humeral impactor tip).The afflicted instrument mwm052 was attached to mwm038 while impacting mwx4ss into the patient.Mwm052 broke into two pieces which were removed, a backup tray was opened, and the surgery was continued normally.
Additional Manufacturer Narrative
Should additional information become available, it will be provided on a supplemental report.
Event or Problem Description
It was reported that there is a broken mwm052 (perform humeral impactor tip).The afflicted instrument mwm052 was attached to mwm038 while impacting mwx4ss into the patient.Mwm052 broke into two pieces which were removed, a backup tray was opened, and the surgery was continued normally.
Additional Manufacturer Narrative
Correction: h6 health impact code.The reported event was confirmed, since the product was returned for evaluation and matches the alleged failure mode.The device inspection revealed the following: visual inspection: the visual inspection of the returned device reveals that the impactor tip has fractured into two separate pieces.Several external impact marks are evident on the tip's surface.The observed breakage pattern, originating from the specimen¿s edge and characterized by v-shaped features, suggests catastrophic failure likely due to rough handling or excessive application of mechanical force.A review of the device history for the reported lot did not indicate any abnormalities.This issue has been addressed by a corrective action.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.Based on investigation, the root cause was attributed to a user related issue.Most likely, the event was caused by application of excessive mechanical force.If more information is provided, the case will be reassessed.

• Brand Name: PERFORM HUMERAL IMPACTOR TIP SIZE 3/4
• Common Device Name: IMPACTOR
• Manufacturer (Section D): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer (Section G): TORNIER INC; 10801 nesbitt avenue s; bloomington MN 55437
• Manufacturer Contact: cécile lefeuvre ; 325 corporate drive; mahwah, NJ 07430 ; 2018315000
• MDR Report Key: 22175695
• Report Number: 0001649390-2025-00395
• Device Sequence Number: 15411382
• Product Code: HWA
• UDI-Device Identifier: 00846832082803
• UDI-Public: (01)00846832082803(11)210129(21)CV0220363
• Combination Product (Y/N): N
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/06/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: MWM052
• Device Lot Number: CV0220363
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/14/2025
• Supplement Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 08/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/29/2021
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown